Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
tenofovir disoproxil phosphate
Zentiva k.s.
J05AF07
tenofovir disoproxil
Antivirals for systemic use
HIV Infections
HIV‑1 infectionTenofovir disoproxil Zentiva is indicated in combination with other antiretroviral medicinal products for the treatment of HIV‑1 infected adults.In adults, the demonstration of the benefit of tenofovir disoproxil in HIV‑1 infection is based on results of one study in treatment‑naïve patients, including patients with a high viral load (> 100,000 copies/ml) and studies in which tenofovir disoproxil was added to stable background therapy (mainly tritherapy) in antiretroviral pre‑treated patients experiencing early virological failure (< 10,000 copies/ml, with the majority of patients having < 5,000 copies/ml).Tenofovir disoproxil Zentiva is also indicated for the treatment of HIV‑1 infected adolescents, with NRTI (nucleotide reverse transcriptase inhibitor) resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years.The choice of Tenofovir disoproxil Zentiva to treat antiretroviral‑experienced patients with HIV‑1 infection should be based on individual viral resistance testing and/or treatment history of patients.Hepatitis B infectionTenofovir disoproxil Zentiva is indicated for the treatment of chronic hepatitis B in adults with:compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis (see section 5.1);evidence of lamivudine-resistant hepatitis B virus (see sections 4.8 and 5.1);decompensated liver disease (see sections 4.4, 4.8 and 5.1).Tenofovir disoproxil Zentiva is indicated for the treatment of chronic hepatitis B in adolescents 12 to < 18 years of age with:compensated liver disease and evidence of immune active disease, i.e. active viral replication, persistently elevated serum ALT levels and histological evidence of active inflammation and/or fibrosis (see sections 4.4, 4.8 and 5.1).
Revision: 13
Authorised
2016-09-15
58 B. PACKAGE LEAFLET 59 PACKAGE LEAFLET: INFORMATION FOR THE USER TENOFOVIR DISOPROXIL ZENTIVA 245 MG FILM-COATED TABLETS tenofovir disoproxil READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Tenofovir disoproxil Zentiva is and what it is used for 2. What you need to know before you take Tenofovir disoproxil Zentiva 3. How to take Tenofovir disoproxil Zentiva 4. Possible side effects 5. How to store Tenofovir disoproxil Zentiva 6. Contents of the pack and other information If Tenofovir disoproxil Zentiva has been prescribed for your child, please note that all the information in this leaflet is addressed to your child (in this case please read “your child” instead of “you”). 1. WHAT TENOFOVIR DISOPROXIL ZENTIVA IS AND WHAT IT IS USED FOR Tenofovir disoproxil Zentiva contains the active substance tenofovir disoproxil. This active substance is an antiretroviral _ _ or antiviral medicine which is used to treat HIV or HBV infection or both. Tenofovir is a nucleotide reverse transcriptase inhibitor, generally known as an NRTI and works by interfering with the normal working of enzymes (in HIV reverse transcriptase; in hepatitis B DNA polymerase) that are essential for the viruses to reproduce themselves. In HIV Tenofovir disoproxil Zentiva should always be used combined with other medicines to treat HIV infection. TENOFOVIR DISOPROXIL ZENTIVA IS A TREATMENT FOR HIV (HUMAN IMMUNODEFICIENCY VIRUS) infection. The tablets are suitable for: • ADULTS • ADOLESCENTS AGED 12 TO LESS THAN 18 YEARS Lue koko asiakirja
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Tenofovir disoproxil Zentiva 245 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains tenofovir disoproxil phosphate (equivalent to 245 mg of tenofovir disoproxil). Excipient with known effect: Each tablet contains 203.7 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Oblong-shaped, light blue colored film-coated tablets with dimensions approx. 17.2 x 8.2 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HIV-1 infection Tenofovir disoproxil Zentiva is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults. In adults, the demonstration of the benefit of tenofovir disoproxil in HIV-1 infection is based on results of one study in treatment-naïve patients, including patients with a high viral load (> 100,000 copies/ml) and studies in which tenofovir disoproxil was added to stable background therapy (mainly tritherapy) in antiretroviral pre-treated patients experiencing early virological failure (< 10,000 copies/ml, with the majority of patients having < 5,000 copies/ml). Tenofovir disoproxil Zentiva is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years. The choice of Tenofovir disoproxil Zentiva to treat antiretroviral-experienced patients with HIV-1 infection should be based on individual viral resistance testing and/or treatment history of patients. Hepatitis B infection Tenofovir disoproxil Zentiva is indicated for the treatment of chronic hepatitis B in adults with: - compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis (see section 5.1). - evidence of lamivudine-resistant hepatitis B virus (see sec Lue koko asiakirja